Left atrial appendage devices and methods

ABSTRACT

Devices and methods for clamping tissue and/or moving two tissue structures together by moving two plates or arm together. The pressure or force applied to the tissue may be used to bring the tissue together, to seal an opening or to cut through and remove a portion of the tissue. In one procedure disclosed, a clip applier may be used to apply one or more clips to the left atrial appendage of the heart to prevent clots from the left atrial appendage from embolizing and causing harm to the patient, such as a stroke.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 10/988,003filed Nov. 12, 2004, which is a continuation-in-part of application Ser.No. 10/310,675 filed Dec. 4, 2002, which claims priority to U.S.Provisional Patent Application Ser. No. 60/337,070, filed Dec. 4, 2001.This application also claims priority of U.S. Provisional PatentApplication Ser. No. 60/519,359, filed Nov. 11, 2003. The entirecontents of the above applications are hereby incorporated by referencein their entirety.

FIELD OF THE INVENTION

The present invention pertains to apparatus and methods formanipulating, positioning, clamping and stapling tissue. In particularit is a clamping device, which is particularly useful for treating theleft atrial appendage of the heart to treat atrial fibrillation, but mayalso be useful for treatment of other tissues including the stomach, ingastric or bariatric surgery, or the lungs.

BACKGROUND OF THE INVENTION

Atrial fibrillation (AF) is a heart beat rhythm disorder (or “cardiacarrhythmia”) in which the upper chambers of the heart known as the atriaquiver rapidly instead of beating in a steady rhythm. This rapidquivering reduces the heart's ability to properly function as a pump. AFis characterized by circular waves of electrical impulses that travelacross the atria in a continuous cycle. It is the most common clinicalheart arrhythmia, affecting more than two million people in the UnitedStates and some six million people worldwide.

Atrial fibrillation typically increases the risk of acquiring a numberof potentially deadly complications, including thrombo-embolic stroke,dilated cardiomyopathy and congestive heart failure. Quality of life isalso impaired by common AF symptoms such as palpitations, chest pain,dyspnea, fatigue and dizziness. People with AF have, on average, afive-fold increase in morbidity and a two-fold increase in mortalitycompared to people with normal sinus rhythm. One of every six strokes inthe U.S. (some 120,000 per year) occurs in patients with AF, and thecondition is responsible for one-third of all hospitalizations relatedto cardiac rhythm disturbances (over 360,000 per year), resulting inbillions of dollars in annual healthcare expenditures.

AF is the most common arrhythmia seen by physicians, and the prevalenceof AF is growing rapidly as the population ages. As the prevalence of AFincreases, so will the number of people who develop debilitating orlife-threatening complications, such as stroke. According to FraminghamHeart Study data, the stroke rate in AF patients increases from about 3%of those aged 50-59 to more than 7% of those aged 80 and over. AF isresponsible up to 35% of the strokes that occur in people older than age85.

Efforts to prevent stroke in AF patients have so far focused primarilyon the use of anticoagulant and antiplatelet drugs, such as warfarin andaspirin. Long-term warfarin therapy is recommended for all AF patientswith one or more stroke risk factors, including all patients over age75. Studies have shown, however, that warfarin tends to beunder-prescribed for AF. Despite the fact that warfarin reduces strokerisk by 60% or more, only 40% of patients age 65-74 and 20% of patientsover age 80 take the medication, and probably fewer than half are on thecorrect dosage. Patient compliance with warfarin is problematic, and thedrug requires vigilant blood monitoring to reduce the risk of bleedingcomplications.

Electrophysiologists classify AF by the “three Ps”: paroxysmal,persistent, or permanent. Paroxysmal AF—characterized by sporadic,usually self-limiting episodes lasting less than 48 hours—is the mostamenable to treatment, while persistent or permanent AF is much moreresistant to known therapies. Researchers now know that AF is aself-perpetuating disease and that abnormal atrial rhythms tend toinitiate or trigger more abnormal rhythms. Thus, the more episodes apatient experiences and the longer the episodes last, the less chance ofconverting the heart to a persistent normal rhythm, regardless of thetreatment method.

AF is characterized by circular waves of electrical impulses that travelacross the atria in a continuous cycle, causing the upper chambers ofthe heart to quiver rapidly. At least six different locations in theatria have been identified where these waves can circulate, a findingthat paved the way for maze-type ablation therapies. More recently,researchers have identified the pulmonary veins as perhaps the mostcommon area where AF-triggering foci reside. Technologies designed toisolate the pulmonary veins or ablate specific pulmonary foci appear tobe very promising and are the focus of much of the current research incatheter-based ablation techniques.

Although cardiac ablation devices and methods are currently available,many advances may still be made to provide improved devices and methodsfor ablating epicardial tissue to treat AF and other arrhythmias. Forexample, currently available devices can be difficult to position andsecure on epicardial tissue to perform an ablation. Devices such asbipolar ablation clamps and others can ablate tissue only in verylimited patterns, such as one or two straight lines. Ablation devicesoften have no means for shielding ablative energy, to avoid unwantedburning of tissues in the vicinity of the heart, such as the esophagus.Relatively few devices can be secured to epicardial tissue withsufficient force to allow for stabilization of the heart. And manyablation devices may not be introduced by minimally invasive means, thusrequiring an open surgical procedure. Typically, therefore, currentcardiac ablation procedures for AF treatment still require stopping theheart and using a cardiopulmonary bypass apparatus. Many of theseshortcomings are addressed by devices and methods described inco-pending U.S. patent application Ser. No. 10/272,446, filed by theinventor of the present application on Oct. 15, 2002, the fulldisclosure of which is hereby incorporated by reference.

One possible mechanism for problems caused by AF is clots from the leftatrial appendage embolizing and causing harm to the patient, such as astroke. Therefore, one desirable procedure to prevent complications fromAF is to prevent or reduce the likelihood of flow out of the left atrialappendage. Disclosed herein are methods and apparatus to treat tissueand are especially applicable to treatment of the left atrial appendage.

BRIEF SUMMARY OF THE INVENTION

In general, the present invention provides a device for manipulatingand/or positioning tissue, such as clamping the left atrial appendage.Of particular interest is providing a device capable of bringing twotissue structures together. In one procedure, a clip applier may be usedto apply one or more clips to the left atrial appendage of the heart toprevent clots from the left atrial appendage from embolizing and causingharm to the patient, such as a stroke. Clips are typically configured tosegregate the left atrial appendage without severing the appendage, butotherwise any suitable configuration is contemplated. In one embodiment,clip applier may be used to simultaneously clip and excise the atrialappendage.

A basic version of the invention is a tissue clamping device or clip foraltering the configuration of tissue including: a first elongated plate,a second elongated plate, a first connector connecting the ends of thefirst and second elongated plates, and a locking mechanism for lockingthe tissue clamping device in a closed position. The plates of the clipmay be the same or different curvatures forming various shapes,including an opening with tapered ends, oval, ovoid, crescent, etc.

Another version of the invention includes an inflatable balloon ormembrane located between two plates that are connected together at bothends. Rows of teeth may be located along the two edges of the opposingplate and are configured to extend beside one or both longitudinal edgesof the balloon. For temporary installation, the balloon may be filedwith a gas, saline or other fluid. For more permanent installation, theballoon may be filled with a material that will change phase over time,such as epoxy. In this case the balloon is filled and the epoxy isallowed to set. One or more applier devices may be used to place andactuate the inflatable balloon clip. The applier would include a fluidsource in fluid communication with the balloon and a cutter and/orcrimping tool to disconnect the balloon from the fluid source.

A further version of the invention includes a pair of flexible armsforming the end of one arm or plate of the clip to create the lockingmechanism. The flexible arms fit within recesses in locking arms orposts extending from the opposing plate of the clip. To create a lowprofile a detent may be located in the flexible arms to allow the top ofthe locking arm to rest therein. One or more applier devices may be usedto place and actuate the flexible arm clip. Projections on the appliermay be set to engage openings in the flexible arms. Manipulation of theprojections allows the flexible arms to be moved into the recesses tolock the clip in the closed position.

Yet a further version of the invention includes a cabled clip. Thisversion has two plates and a cable. The cable extends from one end ofthe first plate, through a first cable opening in the first end of thesecond plate, through a second cable opening in the second end of thesecond plate, and through a third cable opening in the second end of thefirst plate. When the cable is pulled, it forces the plates into closerproximity, thereby clamping any tissue located therebetween. To hold thecable in place, teeth may extend from one or both sides of the cable.The teeth are configured to coordinate with one or more locking teeth inthe third cable opening, thereby allowing the cable to move in only onedirection through the opening. One or more applier devices may be usedto place and actuate the cable clip. The applier device(s) may include agrip for holding the clip and a grip for holding the cable. While theclip is held, the cable is pulled. To prevent overcompression of thetissue a tension limiter may be used. The tension limiter may take theform of a weak point somewhere along the length of the cable, a limit onthe amount of force a coordinating applier is capable of delivering,and/or a motion stop to prevent the cable motion or the plate motion.Other variations of the cable clip may use one or two worm gears onstraight or inclined tracks to drive the motion of the cable.

Another version of the clip has two movable arms connected by a hinge.The hinge may be a pin hinge, living hinge or other pivot means. One ormore applier devices may be used to place and actuate the flexible armclip. The applier has a shaft and the arms of the clip are moveable withrespect to the shaft. The applier and clip may be configured to move thearms and the corresponding tissue simultaneously, sequentially or tomove only one of the two tissue structures.

The clips described above may be configured to enclosed a distal portionof the tissue to be clamped. Further, the clips may be configured toapply sufficient compression to the two tissue structures located in theclip, such that contact between the tissue structures is maintainedunder normal anatomical circulatory pressures of a patient. The arms orplates may be designed to apply approximately evenly distributed forceor pressure along the length of the clip or alternately may be designedto apply greater force or pressure at one or more selected locationsalong the length of the clip. If desired, the clip may be closed ortightened in stages, such that after an initial amount of closure, theclip and/or tissue may be further adjusted prior to applying the fullforce to be eventually used. The device may also incorporate amechanical or electrical/mechanical sensor that determines with adequatecompression has been applied.

The motion of the clip and the associated motions of the applier, may bedriven by any suitable mechanism, including but not limited tomechanical advantage, CO₂ pressure, vacuum pump, AC and/or DC power. Thetissue may also be manipulated using an additional arm mounted on theclip, the clip applier or on a separate device. The additional arm maytake the form of a probe, a grasping element, a vacuum source, a cutterand/or ablation device. These additional devices may be used before,during or after clip application.

Any of the above-indicated clips may also include any one or moreoptions devices. Tissue engaging projections or fasteners, such asspikes, staples, rivets, sutures, and clips, may extending from one orboth of the arms or plates. The tissue fasteners may be formed of aresilient, elastic or superelastic material. The tissue fasteners may beintegrally formed with the arms of the clip, mounted within the clip ormounted within a cartridge that may be loaded into the clip. Analternate form of tissue attachment may be provided by a layer ofadhesive on one or both arms of the clip. An energy source, such as RFor laser, may be used to treat or ablate the tissue near or within theclip. Clot detections devices may be mounted on the clip or on theapplier and one or more needles may be used to withdrawn detected clots.A vacuum source may be connected to the needles to use suction towithdraw the clots. Additionally, the device may incorporate a sensor,such as UV, IR or electrical, that has the ability to determineelectrical block and/or transmurality.

The tissue clamping device may be formed of a resilient material,thereby continuing to apply direct pressure to the tissue enclosedwithin the clip after the clip has been closed.

The tissue clamping device is used to alter the natural proximity of twotissue structures by displacing a first and second tissue structure witha tissue clamping device; bringing the first tissue structure intocontact with the second tissue structure; and applying sufficientpressure with the tissue clamping device to the first and second tissuestructures such that intimate contact between the first and secondtissue structures is maintained under normal anatomical circulatorypressures of the cardiovascular system. The tissue clamping device maybe used temporarily during surgery or it may be permanently applied. Theclip and clip applier may be used directly or through anotherinstrument, such as a visualization device, cannula or other surgicalinstrument. If used for treating the left atrial appendage, the tissueclamping device may be applied via a direct intercostal approach betweenthe 4^(th) thru 6^(th) intercostals space.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a perspective view of a clip having an inflatable balloon;

FIG. 1B shows the clip of FIG. 1A with the balloon inflated;

FIGS. 2A-2C show the clip of FIG. 1A being applied to the left atrialappendage of a heart.

FIG. 3A shows a perspective view of a flexible arm clip having spikesand a low profile locking mechanism;

FIG. 3B shows the clip of FIG. 3A in the locked position;

FIGS. 4A-4C show the clip of FIG. 3A being applied to the left atrialappendage of a heart.

FIG. 5A shows a perspective view of a clip having a cable and plateconfiguration;

FIG. 5B shows the clip of FIG. 5A with the clip in the closed position;

FIGS. 6A-6C show the clip of FIG. 5A being applied to the left atrialappendage of a heart.

FIG. 7A is a perspective view of clip having needles for entering intothe left atrial appendage and a suction lumen.

FIG. 7B is a perspective view of a clip have a replaceable cartridge.

FIGS. 8A and 8B show a clip tension limiter.

FIGS. 9A and 9B show clips using a worm gear as an actuation mechanism.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A and 1B show perspective views of an inflatable clip 100 havinga balloon 102 between the two plates 104, 106 forming the arms of theclip 100. FIG. 1A shows the inflatable clip 100 prior to inflation. InFIG. 1B, the balloon 102 has been inflated and the inflation tube 108 ishas been crimped to provide permanent closure. In this embodiment, thetop plate 104 of the inflatable clip 100 has one, two or more rows oftraction tines or teeth 110 extending downward. The teeth 110 arelocated at or near the edge of the top plate 104 to allow the teeth 110to puncture the left atrial appendage LAA on either side of the balloon102 when the clip 100 is moved to the closed position. The balloon 102is attached to the lower plate 106 of the inflatable clip 100. Theballoon 102 extends along most or all of the length of the clip 100. Theballoon 102 is sized and located such that as the balloon 102 inflates,the edges of the balloon 102 do not extend into the path of the teeth110. The balloon 102 is inflated through a fill tube 108 extending fromone end or side of the balloon 102 and out the end of the inflatableclip 100. If preferred, the orientation of the balloon 102 and teeth 110may be reversed so that balloon 102 is attached to the top plate 104 andthe teeth 110 extend from the lower plate 106.

FIGS. 2A-2C show the clip 100 of FIG. 1A being applied to the leftatrial appendage LAA of a heart H. In FIG. 2A, a clip applier 150 isshown holding one end of the inflatable clip 100 to move the clip 100over the end of the left atrial appendage LAA and to the base of theleft atrial appendage LAA. In FIG. 2B, the balloon 102 has beeninflated. If the clip 100 is being temporarily installed for use duringa surgical procedure, the balloon 102 may be inflated with gas, salineor other liquid. Once the surgical procedure is complete, the saline maybe removed to deflate the balloon 102 and allow removal of the clip 100.If the clip 110 is being used as a permanent or semi-permanent implant,the balloon 102 may be filled with saline, etc. or with a substance thesets, hardens or otherwise changes phase, such as epoxy. In this mode,the balloon 102 would be inflated with the epoxy. Once the epoxy hadhardened, the inflation tube 108 may be crimped and cut with the clipapplier 150 or other cutting tool. In FIG. 2C, the clip applier 150 hasbeen removed and the inflatable clip 100 is permanently orsemi-permanently attached to clamp the base of the left atrial appendageLAA. If necessary, the inflatable clip 100 may be removed by cutting oneor both connector ends 112, 114, which extend between and connect thetop plate 104 and the bottom plate 106. Once one or both of theconnectors 112, 114 have been cut, the inflatable clip 100 may beremoved.

FIGS. 3A and 3B show perspective views of a spiked, flexible arm clip300. In FIG. 3A, the flexible arm clip 300 is in the open position inpreparation for installation. In FIG. 3B, the flexible arm clip 300 isin the locked position. The flexible arm clip 300 has a top plate 304and a bottom plate 306. Although spikes 310 may be located on the topplate 304, the bottom plate 306 or both top and bottom plates 304, 306,in the embodiment shown, spikes 310 are shown extending from both plates304, 306. The spikes 310 are sized and configured to extend into thetissue being clamped to provide traction and inhibit unwanted motion ofthe clip 300 after installation. The closure mechanism 320 includes twoarms 322 forming one end of the top plate 304, the two arms 322 areflexible such that they may be moved toward one another. The arms 322are biased to remain straight. When the flexible arm clip 300 is in theclosed position, the edges of the flexible arms 322 are located withinrecesses 326 created by locking arms 324. The locking arms 324 extend upfrom the bottom plate 306 and have a lateral extension forming the top328 of the recess 326. If a low profile is desired, detents 330 may becut into to the top surface of the top plate 304. In this case, when theclip 300 is in the locked position the lateral extensions 328 of thelocking arms 324 rests in the detents 330. One version of the flexiblearms 322 is created by a slot 332 extending in from one end of the topplate 304. At the end of the slot 332 is a circular opening 334. Thenarrowed section 336 of the top plate 304 adjacent the circular opening334 creates a flexure point for the flexible arms 322 to bend. For easeof manipulation of the flexible arms 322, the ends of the arms 322 mayhave holes 338 extending partially or entirely therethrough.

An alternate version of this embodiment could utilize a single top armwithout the flexible arms. In this case, movable locking arms could bemoved to engage the edges of the top arm, thereby keeping the clip inthe clamped or locked position. The detents may also be used with thisembodiment to provide a low profile.

FIGS. 4A-4C show the clip 300 of FIG. 3A being applied to the leftatrial appendage LAA of a heart H. In FIG. 4A, the flexible arm clip 300is held by a clip applier 350. Two posts 352 on the clip applier 350extend through the holes 338 in the ends of the flexible arms 322,thereby holding the arms 322 close together. The clip 300 is slid overthe end of the left atrial appendage LAA and to the base thereof. Oncein place, a hinged arm 354 of the clip applier 350 moves the top plate304 of the clip 300 towards the bottom plate 306. As the clip 300 isclosed, the spikes 310 pierce the tissue and the flexible arms 322 arelowered toward the locking arms 324. Once fully closed, the flexiblearms 322 are released into place beneath the lateral extensions 328 ofthe locking arms 324, thereby holding the clip 300 in the closedposition. Once closed, the clip applier 350 releases the clip 300 andthe clip applier 350 is removed as seen in FIG. 4C.

If removal of the clip 300 is required, the flexible arms 322 of the topplate 304 of the clip 300 may be squeezed together, thereby removingthem from beneath the lateral extension 328 of the locking arms 324.Once out of the recess 326, the clip 300 may be opened and removed.Alternately, the locking arms 324 may be cut to release the flexiblearms 322 or the opposite end 340 of the clip 300, which connects the topplate 304 and the bottom plate 306, may be cut to separate the top plate304 from the bottom plate 306.

FIGS. 5A and 5B show perspective views of a cable clip 500 in the openand closed position, respectively. The top plate 304 of the clip 500 hasa plurality of optional spikes 510 extending down from the bottomsurface thereof. A cable opening 514, 516 extends through the top plate504 at or near either end of the top plate 504. A cable 512 or wireextends from the bottom plate 506 through the two cable openings 514,516 in the top plate 504 and through a cable opening 518 in the bottomplate 506. In this version, the cable opening 518 in the bottom platehas one or more teeth 520 on one or both of the inside or outside wall.The cable 512 passing therethrough also has mating teeth 522, therebyallowing the cable 512 to move through the opening 518 in only onedirection. Alternately, a ratchet device or other direction specificmechanism may be used.

To prevent excessive force being applied, a tension limiter 530 may beadded to the device. The tension limiter may be created by forming aweak or frangible point 530 in the cable 512 designed to break when apreselected tension is reached or exceeded. A suitable location for thebreak point would be a location at or near the tab 532 at the end of thecable 512, preferably in a location which would have passed through thedirectional opening 518 prior to reaching the maximum tension. Thiswould allow the clip 500 to maintain the maximum pressure after thetension is reached. If preferred, the frangible point 530 could belocated along the main body of the cable 512, in order cause the cable512 to be disabled if excessive force were reached. Alternately or incombination with the frangible point 530, a projection or stop 532 mayextend from a preselected location on the cable 512 to limit thedistance the cable 512 may be pulled. Other versions could utilize arotational stop or penetration stop to prevent the distal end 534 of thecable 512 from rotating beyond a selected point or limiting how closetogether the top plate 504 and bottom plate 506 of the cable clip 500could become. Another tension limiting option is to prevent the clipapplier 550, seen in FIGS. 6A-6C, from applying excessive force. Thismay be accomplished by creating an electronic or mechanical limit to theforce the applier 550 can apply. The sensor for detecting the forceapplied could be a mechanical sensor or electro-mechanical sensor.

FIGS. 6A-6C show the clip 500 of FIG. 5A being applied to the leftatrial appendage LAA of a heart H. In FIG. 6A, one end of the bottomplate 506 of the cable clip 500 is held by a clip applier 550. Forconvenience, the end tab 532 of the cable 512 may be pre-engaged with agrip 552 of the applier 550. The cable clip 500 is slid over the end ofthe left atrial appendage LAA and to the base thereof. Once in place,the grip 552 pulls or grasps and pulls the cable 512 by the tab 532,thereby pressing the top plate 504 down towards the bottom plate 506causing the spikes 510 to enter the upper surface of the tissue, as seenin FIG. 6B. If a directional opening 518 is used in the proximal end 536of the clip 500, once the cable clip 500 is tighten or closed, the clipapplier 550 releases the end of the bottom plate 506 and the clipapplier 550 is removed as seen in FIG. 6C.

The cable clip 500 is especially well suited for situations where theclip 500 may need adjustment after partial installation on the tissue.For example, the cable clip 500 may be placed over the left atrialappendage LAA and slid toward the base thereof. Once, the coarseadjustment has been completed, the cable 512 is pulled a first amount tobring the top plate 504 into closer proximity to the tissue and thelower plate 506. Additional adjustment to the location of the clip 500may be made at this point. Once in final position, the cable 512 ispulled further to bring the tissue into closer proximity and seal theleft atrial appendage LAA. The initial amount may be selected such thatthe clip 500 surrounds, but does not engage the tissue. Alternatively,the amount may be selected to partially engage the tissue, but stillallow the clip 500 to slide along the surface of the tissue. Similaractions may also be used with the other clips described herein topartially close the clip prior to providing the total force to beultimately applied to the clip. Versions with no or short spikes orrounded projections may be well suited for this type of procedure.

FIG. 7A is a perspective view of clip 700 having needles 702 forentering into the left atrial appendage LAA and a suction lumen 708.This version of the clip 700 includes opposable arms 704, 706 connectedwith a hinge 712. The range of motion of the arms 704, 706 may be varieddepending on the particular use of the clip 700. For example, fortreatment of the left atrial appendage LAA, the range may be up to a90-degree angle. The clip 700 could include a permanent or adjustablestop 714 to prevent the arms from being opened too far. The hinge 712for the arms 704, 706 may be a living hinge, a pin hinge as shown, orother known hinge means. The example shown and described has two arms704, 706. However, other this embodiment and the other versions could beused with additional arms or auxiliary devices. For example, anadditional parallel, arm for stabilizing or manipulating the tissueduring actuation of the device may be used. Furthermore, the clip 700could be applied using one or more other standard or specializeddevices. For example, the clip 700 could be mounted on a clip applier750 and used with forceps or other devices using mechanical engagementor positive or negative pressure to manipulate, pierce, or otherwisetreat or interact with the tissue.

The arms 704, 706 of the clip 700 may be selected to conform to theshape of the tissue to be clamped. For matching the shape of the leftatrial appendage LAA, an ovoid or clam shape may be used, as seen inFIG. 7A. For matching the shape of the body of the heart H, similarlycurved top and bottom arms are used, as seen in FIGS. 1A-6C. Matchingthe tissue shape promotes non-traumatic grasping. To further protect thetissue, a flexible sheet-like 716 element such as gauze or an adhesivefilm may be used between the arm 704, 706 and the tissue, therebyallowing the user to grasp tissue without damaging it.

The clip 704, 706 may be created with several different lengths andshapes of arms 704, 706 for different sizes and configurations of tissueand organs. Also, the arm length could be adjustable. For example, thearm 704, 706 could move along a sliding track 718 thereby moving theextending or shortening the length of the arms 704, 706, as seen in FIG.7A. The adjustable length allows the clip 700 to vary the clamped ortreated length according to the anatomy of the tissue being treated orthe procedure being performed.

Any of the embodiments discussed herein may have one or more additionaloptional devices added to the arms or body of the device. These include,but are not limited to spikes, staples 710, rivets, sutures 720, tracksfor the addition of other materials, drug therapies, RF ablation ortreatment, laser ablation or treatment, needles 702, clot detectiondevices, actuation augmenting devices, etc. These optional devices arediscuss in further detail below.

The clip 700 may be used to staple tissue, in which case, one, two,three or more rows of staples 710 may be loaded into one or both arms704, 706. The staples 710 may be loaded individually into openings inthe arm 704, 706, or a replaceable or removable cartridge 760, seen inFIG. 7B, may be used to hold or load a set of staples 710. A pluralityof different cartridges may be used having different numbers,configurations and lengths of staples 710. Each cartridge could also beoptimized to provide specific staple patterns for different patients,different organs and/or organ specific needs. For example, wider and/orlonger staples may be located toward the middle of the clip 700 toaccommodate thicker tissue, while narrower and/or shorter staples 710may be located toward the edges of the clip 700. Further, the staples710 and other types of fasteners mounted to the arms 704, 706 may beconfigured with a length to penetrate only the outer surface of thetissue, through one tissue structure, through both tissue structures orthrough both tissue structures and engage the opposing arm 704, 706. Forexample, spikes may be designed to extend from both arms and each setdesigned to pierce approximately one tissue thickness. In this case thetips of the spikes would be close to or at the same level in the tissue.The spikes could be placed to pierce different locations of the tissueor, if designed to be at or short of full penetration, the spikes couldbe aligned. A staple type fastener could be designed to extend throughboth thickness of the tissue and extend into or through openings in theopposing arm of the clip. The staple ends could then be manually orautomatically bent over or otherwise manipulated to engage the opposingarm. The openings in the arm could be formed by the staple ends piercingthe arm, or the openings may be preformed to align with and bend thestaple ends.

A track, adhesive 716 or other permanent or temporary attachment may beadded or used to connect a scaffold, wire mesh, sealing strip,pericardium, DACRON or other material to one or both arms of any of theversions of the clip device. If used with the staples 710, the staplescould pierce both the material and the tissue, thereby stapling thematerial thereto. A simple form could use longitudinal grooves near theedges of the device arms into which a semi-rigid material may be slid.If a more flexible material is used, a cartridge attachment 760, seen inFIG. 7B, may be attachable to the inside face of the arm 706. Thecartridge 760 would automatically or manually release the sheet ofmaterial 762 when the clamp was actuated. Alternately, a flexiblematerial could be temporarily clamped to the arm of the device. Theadditional material may be used to improve many characteristicsincluding, but not limited to load bearing, stability, sealing and/orhealing of the tissue being treated. Alternate versions could also beused to apply one time or time-release drug therapies, which could haveanti-clotting, antibiotic, healing or other properties. In the one-timedose versions, the material need not be connected to the tissue. Thematerial could remain in place attached to the arm as long as the devicewas attached the tissue and would be removed along with the device oncetreatment was complete. In other versions, an adhesive or otherattachment could connect the material to either or both of the tissuestructures. The adhesive could be used with or in place of the otherfasteners described herein, such as spikes, staples, rivets, sutures,etc.

A mechanism for RF treatment or ablation may be added to one or botharms to treat or ablate the tissue around the treatment site. Similarly,a laser source could be added to treat or ablate tissue. In oneembodiment, an integrated linear laser would be activated from thehandle to deliver treatment or ablation to the tissue. The deliverycould be through the clip or the delivery device.

Fixed or retractable needles 702 may be added to one or both arms 704,706. The needles 702 may be used to inject drug therapies and/or beattached to a suction lumen 708 to remove clots. Additionally, theneedle 702 may be used to monitor the formation or presence of clots todetermine whether or not suction removal of the clot(s) is necessary. Anexample of these needles 702 is shown in FIG. 7A.

The arms 704, 706 may be actuated by many different mechanisms,including a trigger in a pistol grip, a syringe grip, a scissors grip,etc. The manual force applied to the handle may be augmented to reducethe gripping action required to drive the staples and/or arm movement.The augmenting force may be proved by CO₂ pressure, vacuum pump, etc.Power to these devices may be alternating current or battery power.

FIGS. 8A and 8B show a clip 800 having a different version of a tensionlimiter using a threaded rod 854 as an actuation mechanism. One end ofthe bottom plate 806 of the clip 800 is held by a clip applier 850. Acable 812 is located over the top plate 804 of the clip 800 and throughholes 814, 816, 818 passing through the part of the clip 800. The end ofthe cable 812 is threaded 852 to engage the threaded rod 854 locatedwithin the clip applier 850. The clip 800 is slid over the end of theleft atrial appendage LAA and to the base thereof. Once in place, thethreaded rod 854 is twisted to pull the end of the cable 812, therebypressing the top plate 804 down towards the bottom plate 806 causing thespikes 810 to enter the upper surface of the tissue. The torque ortwisting force applied to the threaded rod will dictate the amount ofcompressive force the clip applies. A torque reading may be shown to theuser to indicate the amount of force or the system could use a built inlimit beyond which, the applier would not continue to twist the rod.Various mechanisms may be used to secure the cable 812 for permanentinstallation of the clip 800. For example, the nut or other twist onfastener may be associated with the worm gear 854 and left in place, oran adhesive may be used to permanently fix the end of the cable 812,etc.

FIGS. 9A and 9B show clips using worm gears as actuation mechanisms. InFIG. 9A, a single threaded rod 908 is twisted to pull the top arm 904down toward the bottom arm 906. Once in the clip 900 is closed, thethreaded rod 908 may be glued or otherwise locked into place to hold theclip 900 in the closed position. Alternately, the friction of thethreaded rod 908 against the grooves 910 in the opening 912 of the toparm 904 and the grooves 914 in the opening 916 of the bottom arm 906 maybe sufficient to hold the clip 900 closed. In FIG. 9B, both the top arm904 and the bottom arm 906 each have a set of grooves 920 located on theoutside surface. A V-shaped endcap 922 is placed over the ends of thearms 904, 906. A threaded rod 908 within each side of the endcap 922pulls the ends of the clip 902 together, thereby compressing the tissuelocated within the clip 902. When close, an adhesive may be used to lockthe parts in place, or any other suitable locking mechanism may be used,if needed.

A rivet may be used as the connector to hold together the top and bottomarms of any of the embodiments of the clip discussed herein. The rivetcould be used as the connector only or it may be used to provide closingpressure.

Several of the embodiments described herein use mechanical motion toprovide pressure or force to the tissue being treated. In addition to orinstead of the mechanical force, any of the clips described herein maybe formed of a resilient material, such as NITINOL or other superelasticor elastic material. Using a resilient material allows the clip to bepre-stressed, such that when the clip is closed, the residual forces inthe clip material continue to provide active pressure on the tissuewithin the clip.

Further embodiments may use mechanisms that connect both ends of theclip after two separate pieces are located in place around the tissue tobe treated. Once in place, a latching or locking mechanism may engageone end, then the second end, or the two ends may be connectedsimultaneously.

Another version of the clip would be preloaded or stressed. In thisversion, the clip is made of a resilient material and preformed in theclosed position. For installation, the clip would be deformed to allowthe user to place the clip over the tissue. When the clip is released,the clip would return to the closed position, conforming to the shape ofthe tissue and clamping, compressing or otherwise manipulating thetissue.

When one or more of the clips is used to treat the left atrial appendageLAA, the procedure may be done during full open heart surgery or duringminimally invasive surgery. A possible direct approach to the leftatrial appendage during a minimally invasive procedure would be anintercostal approach between the ribs, in particular an approach betweenthe 4^(th) thru 6^(th) intercostals space. Further, the clip and clipapplier may be introduced via a visualization device.

In some procedures, one or more additional devices may be introducedinto patient as a part of the clip applier or in addition to theapplier. These include devices such as a visualization device,positioning or ablation device, such as one or more of the devicesdescribed in U.S. patent application Ser. No. 10/272,446, which has beenpreviously incorporated by reference. The present invention and theauxiliary devices may be introduced into the patient via a primaryincision placed in any suitable location. For example, in one embodimentthe primary incision comprises a subzyphoid incision, but in otherembodiments a subcostal incision, an intercostal incision or any othersuitable incision may be used. To facilitate introduction ofvisualization device, one or more retractors may be used to increase thesize of an incision. One or more additional incisions on patient mayinclude, for example, an arterial/venous access incision for providingaccess for a perfusion cannula to a cardiopulmonary bypass machine orfor any other device, an incision for a separately-introduced leftatrial appendage clamp or clip, and/or a femoral incision for providingaccess to a femoral artery for entry of a mapping catheter or any otherdevice. Any suitable combination of incisions and devices iscontemplated within the scope of the invention.

Several versions of device applicators are disclosed herein, these maybe configured to partially or completely release once in place over thetissue to be treated. If this is the case an additional tool may be usedto move the device between the open and the clamped or closed position.Releasing or decoupling the device from the applicator avoidstranslation or magnified translation of motion caused by dissimilarmotions between the moving operator and moving tissue structure,minimizing trauma to the tissue structure to be altered.

The actuation of the embodiments may be set to move two armssimultaneously to move two tissue structures together simultaneously orthe arms may be moved separately such that the majority of the motion isprovided by one arm and the associated tissue moving towards the secondtissue and corresponding arm. The pressure or force applied to thetissue may be used bring two tissues closer together, to seal an openingor to cut through and remove a portion of the tissue.

In each of these cases described for treating the left atrial appendage,the force applied to the tissue should be sufficient pressure or forceto create and maintain contact between the top and bottom tissuestructures of the left atrial appendage and to prevent the passage offluid therethrough during pressures up to and/or slightly above normalanatomical circulatory pressure. Once sealed, the appendage may be leftin place or may be partially or completely removed by ablation ordissection.

Each of the clips described herein are designed to enclose the distalend of the at least one tissue structure prior to application of forcesbetween device and tissue. Further, the clips may be designed to applyrelatively even distribution of force along the longitudinal axis of thetissue that is in contact with the clip. In some cases, it may bedesirable to have one or more higher pressure area(s). In these cases,the clip would be configured such that a larger force would be exertedat a chosen location(s) along the length of the clip.

Many features have been listed with particular configurations, options,and embodiments. Any one or more of the features described may be addedto or combined with any of the other embodiments or other standarddevices to create alternate combinations and embodiments.

Although the invention has been fully described above, in relation tovarious exemplary embodiments, various additions or other changes may bemade to the described embodiments without departing from the scope ofthe present invention. Thus, the foregoing description has been providedfor exemplary purposes only and should not be interpreted to limit thescope of the invention as set forth in the following claims.

What is claimed is:
 1. A tissue clamping device for altering theconfiguration of tissue, the tissue clamping device comprising: a firstelongated plate having a first end and a second end, a second elongatedplate having a first end and a second end, a first connector connectingsaid first end of said first elongated plate to said first end of saidsecond elongated plate, wherein said tissue clamping device has a firstposition and a second position, and a locking mechanism for locking saidtissue clamping device in said second position.
 2. The tissue clampingdevice of claim 1, further comprising a second connector connecting saidsecond end of said first elongated plate to said second end of saidsecond elongated plate and an inflatable balloon attached to said firstelongated plate.
 3. The tissue clamping device of claim 2, wherein saidballoon is filled with a material that changes phase to a solid.
 4. Thetissue clamping device of claim 2, wherein said balloon is filled withepoxy.
 5. The tissue clamping device of claim 2, further comprising afill tube extending from an end of said inflatable balloon.
 6. Thetissue clamping device of claim 2, further comprising a row of teethextending from said second elongated plate along a longitudinal edgethereof, such that said row of teeth is located to extend beside alongitudinal edge of said inflatable balloon.
 7. The tissue clampingdevice of claim 6, further comprising a second row of teeth extendingfrom a second longitudinal edge of said second elongated plate, suchthat said second row of teeth is located to extend beside a secondlongitudinal edge of said inflatable balloon.
 8. The tissue clampingdevice of claim 1, further comprising an arm extending from said secondend of said second elongated plate, and wherein said locking mechanismincludes a locking recess located in a post extending from said firstelongated plate wherein a portion of said arm is sized and configured tofit within said locking recess, thereby holding said tissue clampingdevice in said second position.
 9. The tissue clamping device of claim1, wherein said second end of said second elongated plate is formed by afirst arm and a second arm, said first and second arms being movable.10. The tissue clamping device of claim 9, wherein said lockingmechanism includes a first locking recess located in a first postextending from said first elongated plate and a second locking recesslocated in a second post extending from said first elongated plate andwherein a portion of said first arm is sized and configured to fitwithin said first locking recess and a portion of said second arm issized and configured to fit within said second locking recess, therebyholding said tissue clamping device in said second position.
 11. Thetissue clamping device of claim 10, further comprising a first detent insaid first arm and a second detent in said second arm, said first detentsized to engage a top portion of said first post and said second detentsized to engage a top portion of said second post.
 12. The tissueclamping device of claim 9, wherein said first and second arms eachhaving a hole proximate an end thereof.
 13. An applier for applying thetissue clamping device of claim 12, comprising: a movable arm having afirst projection and a second projection sized and configured to engagethe holes in the tissue clamping device of claim 12, a clamp forreleasably engaging a second end of said first elongated plate, a firstactuator for moving said movable arm, and a second actuator forreleasing said clamp from engagement with said second end of said firstelongated plate.
 14. The tissue clamping device of claim 1, wherein saidfirst connector is a cable extending from said first elongated plate,through a first cable opening in said first end of said second elongatedplate, through a second cable opening in said second end of said secondelongated plate, and through a third cable opening in said second end ofsaid first elongated plate.
 15. The tissue clamping device of claim 14,wherein a first side of said cable has a plurality of cable teethextending therefrom and said third cable opening has at least onelocking tooth extending therefrom.
 16. The tissue clamping device ofclaim 14, further comprising a tension limiter to limit a maximumtension on said cable.
 17. An applier for applying the tissue clampingdevice of claim 14, comprising: a first clamp for releasably gripping anend of said cable of the tissue clamping device of claim 14, a secondclamp for releasably engaging a second end of said first elongated platea first actuator for moving said first clamp, thereby moving said end ofsaid cable, and a second actuator for releasing said second clamp. 18.The tissue clamping device of claim 1, wherein said first elongatedplate and said second elongated plate are curved and have similarcurvatures.
 19. The tissue clamping device of claim 1, wherein saidfirst elongated plate and said second elongated plate are curved andhave different curvatures.
 20. The tissue clamping device of claim 1,wherein, when said tissue clamping device is in said second position,the first and second plates form an elongated opening tapering towardssaid first ends of said first and second elongated plates and towardssaid second ends of said first and second elongated plates.
 21. Thetissue clamping device of claim 1, wherein said first and secondelongated plates have curvatures and said curvatures are selected toconform to a shape of the tissue.
 22. The tissue clamping device ofclaim 1, wherein said first and second elongated plates have curvatures,wherein said first and second curvatures are selected such that, whensaid tissue clamping device is in said second position, said first endsof said first and second elongated plates touch, said second ends ofsaid first and second elongated plates touch and a gap remains between amiddle portion of said first elongated plate and a middle portion ofsaid second elongated plate.
 23. The tissue clamping device of claim 22,wherein said gap is oval, ovoid or oval-like.
 24. The tissue clampingdevice of claim 1, wherein said tissue clamping device is configured tosimultaneously move a first tissue structure and a second tissuestructure together.
 25. The tissue clamping device of claim 24, whereinsaid tissue clamping is further configured to apply sufficientcompression to the two tissue structures such that contact between thefirst and second tissue structures is maintained under normal anatomicalcirculatory pressures of a patient.
 26. The tissue clamping device ofclaim 1 used in combination with a tissue clamp applier having anapplier shaft, wherein said first and second elongated plates are bothmoveable with respect to said applier shaft, wherein the motion of saidfirst and second elongated plates is at a hinge.
 27. The tissue clampingdevice of claim 26, wherein said hinge is a living hinge.
 28. The tissueclamping device of claim 26, wherein said hinge is a pin hinge.
 29. Thetissue clamping device of claim 26, wherein the motion of said first andsecond elongated plates is created by a worm gear driven by saidapplier.
 30. The tissue clamping device of claim 29, wherein said wormgear has a straight track.
 31. The tissue clamping device of claim 29,wherein said worm gear has two inclined tracks.
 32. The tissue clampingdevice of claim 26, wherein the motion of said first and secondelongated plates is driven by mechanical advantage.
 33. The tissueclamping device of claim 26, wherein the motion of said first and secondelongated plates is driven by CO₂ pressure.
 34. The tissue clampingdevice of claim 26, wherein the motion of said first and secondelongated plates is driven by a vacuum pump.
 35. The tissue clampingdevice of claim 26, wherein the motion of said first and secondelongated plates is driven by AC or DC power.
 36. The tissue clampingdevice of claim 1, wherein, when said tissue clamping device is in saidfirst position, said first and second elongated plates are configured toenclosed a distal end of the tissue.
 37. The tissue clamping device ofclaim 1, wherein, when said tissue clamping device is in said secondposition, said first and second elongated plates are configured to applyapproximately evenly distributed forces along a longitudinal axis of thetissue clamping device.
 38. The tissue clamping device of claim 1,further comprising a tissue fastener extending from one of said firstand second elongated plates.
 39. The tissue clamping device of claim 1,further comprising a plurality of tissue engaging projections extendingfrom one of said first and second elongated plates.
 40. The tissueclamping device of claim 1, further comprising a plurality of staplesextending from one of said first and second elongated plates.
 41. Thetissue clamping device of claim 1, further comprising a suture extendingfrom at least one of said first and second elongated plates.
 42. Thetissue clamping device of claim 1, further comprising at least onerivet.
 43. The tissue clamping device of claim 1, further comprising atleast one superelastic clip, said superelastic clip preformed to engagea selected portion of tissue.
 44. The tissue clamping device of claim 1,further comprising a tissue cutter adjacent one of said first and secondelongated plates.
 45. The tissue clamping device of claim 1, whereinsaid tissue clamping device is formed of a resilient material, therebycontinuing to apply direct pressure while in said second position. 46.The tissue clamping device of claim 1, further comprising a thirdposition, wherein in said second position, said tissue clamping deviceis applying force to the tissue, and wherein said third is intermediatesaid first and second positions, such that said tissue clamping deviceis proximate the tissue, but is not applying force thereto.
 47. Thetissue clamping device of claim 1, further comprising a vacuum sourceconnected to at least one of said first and second elongated plates. 48.The tissue clamping device of claim 1, further comprising an adhesivelocated on at least one of said first and second elongated plates. 49.The tissue clamping device of claim 1, further comprising an RF energysource connected to at least one of said first and second elongatedplates, thereby allowing ablation of tissue.
 50. The tissue clampingdevice of claim 1, further comprising an laser energy source connectedto at least one of said first and second elongated plates, therebyallowing ablation of tissue.
 51. The tissue clamping device of claim 1,further comprising a stabilizing arm extending from one of said firstand second elongated plates.
 52. The tissue clamping device of claim 1,further comprising a cartridge connectable with at least one of saidfirst and second elongated plates, said cartridge holding a plurality oftissue fasteners.
 53. The tissue clamping device of claim 52, whereinsaid plurality of tissue fasteners are staples.
 54. The tissue clampingdevice of claim 1, further comprising a needle extending from one ofsaid first and second elongated plates.
 55. The tissue clamping deviceof claim 54, wherein said needle is connected to a suction source, saidneedle sized and configured to a clot to enter a distal tip of saidneedle and be withdrawn from a patient by said suction source.
 56. Aclip applier for applying at least one clip to a left atrial appendageof a heart of a patient, the device comprising: an elongate shaftdefining a proximal end and a distal end; clip applying means coupledwith the shaft at or near the distal end; and an actuator coupled withthe shaft at or near the distal end and also coupled with the clipapplying means so as to actuate the applying means to apply the at leastone clip to the left atrial appendage.
 57. A clip applier as in claim56, wherein the device is introducible through a lumen of avisualization device.
 58. A clip applier as in claim 56, furtherincluding at least one clip coupled with the device in a position toallow the clip applying means to apply the clip to the atrial appendage.59. A clip applier as in claim 58, wherein the at least one clip doesnot sever the atrial appendage when applied to the appendage by the clipapplying means.
 60. A tissue clamping device for altering theconfiguration of tissue, the tissue clamping device comprising: a firstelongated plate having a first end and a second end, a second elongatedplate having a first end and a second end, said first end of said secondplate being connected with said first end of said first plate, and saidsecond end of said second plate being connected with said second end ofsaid second plate, an inflatable membrane connected to said first plate,wherein has a first, deflated position and a second, inflated position,and a fill opening in fluid communication with an interior of saidinflatable membrane.
 61. The tissue clamping device of claim 60, furthercomprising a plurality of teeth extending from said second elongatedplate.
 62. The tissue clamping device of claim 61, wherein saidplurality of teeth form a row along a longitudinal edge of said secondelongated plate.
 63. The tissue clamping device of claim 62, whereinsaid row of teeth is located to extend beside a longitudinal edge ofsaid inflatable membrane.
 64. The tissue clamping device of claim 61,wherein said plurality of teeth form a first row and a second row, saidfirst row of teeth located along a first longitudinal edge of saidsecond plate and said second row of teeth located along a secondlongitudinal edge of said second plate.
 65. The tissue clamping deviceof claim 64, wherein said first row of teeth is located to extend besidea first longitudinal edge of said inflatable membrane and said secondrow of teeth is located to extend beside a second longitudinal edge ofsaid inflatable membrane.
 66. The tissue clamping device of claim 60,wherein said balloon is filled with a phase change material.
 67. Thetissue clamping device of claim 60, wherein said balloon is filled withepoxy.
 68. The tissue clamping device of claim 60, further comprising afill tube extending from said fill opening.
 69. The tissue clampingdevice of claim 60, further comprising an RF energy source connected toat least one of said first and second elongated plates, thereby allowingablation of tissue.
 70. The tissue clamping device of claim 60, furthercomprising an laser energy source connected to at least one of saidfirst and second elongated plates, thereby allowing ablation of tissue.71. An applier for applying the tissue clamping device of claim 60,comprising: a grip configured to engage an end of the tissue clampingdevice of claim 60, an inflation solution source in fluid communicationwith said fill opening, and a cutter for disconnecting said inflationsolution source from said fill opening.
 72. The applier of claim 71,wherein said cutter further comprises a crimper.
 73. A tissue clampingdevice for altering the configuration of tissue, the tissue clampingdevice comprising: a first elongated arm having a first end and a secondend, a second elongated arm having a first end and a second end, saidfirst end of said second arm being connected with said first end of saidfirst arm, and a locking arm extending from said first elongated arm,said locking arm configured to engage an engagement portion of saidsecond elongated arm, said tissue clamping device having a firstposition and a second position, wherein, in said first position, saidlocking arm is separated from said second elongated arm, and in saidsecond position, said locking arm engages said engagement portion ofsaid second elongated arm.
 74. The tissue clamping device of claim 73,wherein said second end of said second elongated plate is formed by aflexible arm, said first and second arms being movable and wherein saidengagement portion is located on said flexible arm.
 75. The tissueclamping device of claim 74, wherein said locking arm includes lockingrecess on a side thereof, and wherein a top surface of said lockingrecess engages said engagement portion of said flexible arm.
 76. Thetissue clamping device of claim 75, further comprising a first detent insaid flexible arm and a second detent in said second arm, said firstdetent sized to engage said top portion of said locking recess.
 77. Thetissue clamping device of claim 75, further comprising a second lockingarm extending from said first elongated arm, said second locking armconfigured to engage a second engagement portion of said secondelongated arm, said second locking arm including a second locking recesson a side thereof, and wherein said second end of said second elongatedplate includes a second flexible arm extending generally parallel to thefirst flexible arm, and wherein a top surface of said second lockingrecess engages an engagement portion of said second flexible arm. 78.The tissue clamping device of claim 77, wherein said first and secondarms each having a hole proximate an end thereof.
 79. An applier forapplying the tissue clamping device of claim 78, comprising: a movablearm having a first projection and a second projection sized andconfigured to engage the holes in the tissue clamping device of claim78, a clamp for releasably engaging a second end of said first elongatedplate, a first actuator for moving said movable arm, and a secondactuator for releasing said clamp from engagement with said second endof said first elongated plate.
 80. The tissue clamping device of claim84, further comprising a plurality of projections extending from saidfirst elongated plate.
 81. The tissue clamping device of claim 80,wherein said projections have pointed tips.
 82. The tissue clampingdevice of claim 73, further comprising an RF energy source connected toat least one of said first and second elongated plates, thereby allowingablation of tissue.
 83. The tissue clamping device of claim 73, furthercomprising an laser energy source connected to at least one of saidfirst and second elongated plates, thereby allowing ablation of tissue.84. A tissue clamping device for altering the configuration of tissue,the tissue clamping device comprising: a first elongated plate having afirst end and a second end, a second elongated plate having a first endand a second end, a cable extending from said first elongated plate,through a first cable opening in said first end of said second elongatedplate, through a second cable opening in said second end of said secondelongated plate, and through a third cable opening in said second end ofsaid first elongated plate, wherein said tissue clamping device has afirst position and a second position, and wherein said tissue clampingdevice is moved from said first position to said second position bypulling an end of said cable.
 85. The tissue clamping device of claim84, wherein a first side of said cable has a plurality of cable teethextending therefrom and said third cable opening has at least onelocking tooth extending therefrom.
 86. The tissue clamping device ofclaim 85, wherein said cable teeth and said locking tooth are sized andconfigured to allow the cable to move in a single direction through saidthird cable opening.
 87. The tissue clamping device of claim 84, furthercomprising a plurality of projections extending from said firstelongated plate.
 88. The tissue clamping device of claim 87, whereinsaid projections are spikes.
 89. The tissue clamping device of claim 84,further comprising a plurality of projections extending from said firstelongated plate and said second elongated plate.
 90. The tissue clampingdevice of claim 84, further comprising a tension limiter to limit amaximum tension on said cable.
 91. The tissue clamping device of claim84, further comprising an RF energy source connected to at least one ofsaid first and second elongated plates, thereby allowing ablation oftissue.
 92. The tissue clamping device of claim 84, further comprisingan laser energy source connected to at least one of said first andsecond elongated plates, thereby allowing ablation of tissue.
 93. Anapplier for applying the tissue clamping device of claim 84, comprising:a first gripper for releasably gripping an end of said cable of saidtissue clamping device of claim 84, a second gripper for releasablyengaging a second end of said first elongated plate a first actuator formoving said first gripper, thereby moving said end of said cable, and asecond actuator for releasing said second gripper.
 94. The applier ofclaim 93, wherein said second actuator also releases said first gripper.95. The applier of claim 93, further comprising a third actuator forreleasing said first gripper.
 96. The applier of claim 93, wherein saidfirst actuator is also used to release said first gripper.
 97. A methodof altering the natural proximity of two tissue structures, the methodcomprising the steps of: (a) displacing a first and second tissuestructure with a tissue clamping device; (b) bringing the first tissuestructure into contact with the second tissue structure; (c) andapplying sufficient pressure with the tissue clamping device to thefirst and second tissue structures such that intimate contact betweenthe first and second tissue structures is maintained under normalanatomical circulatory pressures of the cardiovascular system.
 98. Themethod of claim 97, wherein the tissue clamping device is left in placeafter surgery to continue to apply the sufficient pressure of step (c).99. The method of claim 97, wherein the tissue clamping device isapplied under direct visualization of the tissue structure.
 100. Themethod of claim 97, wherein the tissue clamping device is applied to theleft atrial appendage.
 101. The method of claim 100, wherein the tissueclamping device is applied via a direct intercostal approach betweenribs of a patient.
 102. The method of claim 100, wherein the tissueclamping device is applied via a direct intercostal approach between the4^(th) thru 6^(th) intercostals space.
 103. The method of claim 97,wherein a tissue region adjacent to the tissue clamping device isdissected distal to the tissue clamping device.
 104. The method of claim97, further comprising the step of: (d) manipulating at least one of thetissue structures prior to step (a).
 105. The method of claim 104,wherein the manipulation of step (d) is performed by suction.
 106. Themethod of claim 97, wherein step (a) is performed with the use ofsuction applied to a portion of the tissue clamping device.
 107. Themethod of claim 97, wherein step (a) is performed with the use of aseparate suction device.
 108. The method of claim 97, wherein step (a)is performed by direct physical contact applying pressure on said firstand second tissue structures.
 109. The method of claim 108, wherein thedirect pressure is provided by residual stress in a material used tocreate at least a portion of the tissue clamping device.
 110. The methodof claim 109, wherein the residual stress is caused by preforming thetissue clamping device into a shape prior performing steps (a) through(c).
 111. The method claim of 109, further comprising the step offorming the tissue clamping device of a superelastic material.
 112. Themethod of claim 108, further comprising the step of: (d) locking thetissue clamping device in a closed position.
 113. The method of claim97, further comprising the step of: (d) applying at least one staple tomaintain the pressure of step (c).
 114. The method of claim 97, furthercomprising the step of: (d) applying at least one rivet to maintain thepressure of step (c).
 115. The method of claim 97, further comprisingthe step of: (d) applying at least one preformed clip formed of asuperelastic material to maintain the pressure of step (c).
 116. Themethod of claim 97, further comprising the step of: (d) applying atleast one suture to maintain the pressure of step (c).
 117. The methodof claim 97, further comprising the step of: (d) applying RF energy tothe tissue to maintain the contact between the first and second tissuestructures of step (c).
 118. The method of claim 97, further comprisingthe step of: (d) applying an adhesive to maintain the pressure of step(c).
 119. The method of claim 118, wherein the adhesive of step (d) islocated on at least one elongated plate of the tissue clamping device.120. The method of claim 97, further comprising the step of: (d)applying laser energy to the tissue to maintain the contact between thefirst and second tissue structures of step (c).
 121. The method of claim97, wherein a device applicator is used to control the tissue clampingdevice.
 122. The method of claim 121, wherein the tissue clamping deviceis decoupled from the device applicator once the tissue clamping deviceis fastened to at least one of the tissue structures in order to avoidtransmitting large forces from the device applicator to the tissuestructure, thereby avoiding causing damage to the tissue structure. 123.The method of claim 121, wherein the tissue clamping device is decouplefrom the device applicator prior to fastening the tissue clamping deviceto the tissue structures, thereby minimizing trauma to the tissuestructures.
 124. The method of claim 97, wherein the tissue structuresare displaced simultaneously.
 125. The method of claim 97, wherein thetissue structures are displaced sequentially.